Thrombosis
Conditions
Keywords
Anticoagulation, Prophylaxis, Desirudin, Direct thrombin inhibitor, Heparin-induced thrombocytopenia
Brief summary
The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
Detailed description
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
Interventions
DRUGDesirudin
Desirudin SC 15mg q12h
Sponsors
Canyon Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent before initiation of any study related procedures. 2. Be at least 18 years of age. 3. Patients requiring anticoagulation for the prophylaxis of thrombosis. 4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.
Exclusion criteria
1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test). 2. Intracranial neoplasm, arteriovenous malformation or aneurysm. 3. Severe renal insufficiency (chronic or acute) with a GFR of \< or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula. 4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product 5. Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable). 6. Refusal to undergo blood transfusion should it become necessary 7. Active bleeding or irreversible coagulation abnormality. 8. Uncontrolled hypertension defined as a blood pressure \> or equal to 180/110 mmHg. 9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO. 10. Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Bleeding | 24 hours after last dose of study drug | Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis | Up until 24 hours after last dose of study drug | * New onset symptomatic thrombosis requiring medical or surgical intervention; * Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited between April 5, 2010 and February 18, 2011. Patients were recruited from inpatient medical and surgical services as well as surgical clinics when presenting for pre-operative services.
Participants by arm
| Arm | Count |
|---|---|
| Desirudin desirudin 15 mg twice daily for a minimum of 5 days | 516 |
| Total | 516 |
Baseline characteristics
| Characteristic | Desirudin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 129 Participants |
| Age, Categorical Between 18 and 65 years | 387 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 516 participants |
| Sex: Female, Male Female | 314 Participants |
| Sex: Female, Male Male | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 382 / 516 |
| serious Total, serious adverse events | 80 / 516 |
Outcome results
Primary
Major Bleeding
Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
Time frame: 24 hours after last dose of study drug
Population: All patients receiving at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desirudin | Major Bleeding | 0 participants |
Secondary
Thrombosis
* New onset symptomatic thrombosis requiring medical or surgical intervention; * Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction.
Time frame: Up until 24 hours after last dose of study drug
Population: Patients who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desirudin | Thrombosis | 8 participants |